Tracheobronchial Suction Catheter Kit
Who Makes This Device Type in China?
9 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Guangdong and Zhejiang, and 2 other provinces. 3 of them are contract manufacturers, able to build to a buyer’s own specification.
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Amsino Medical (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Allmed Industrial Limited Guangdong
- Dongguan Hong De Medical Plastic Products Co., Ltd. Guangdong, contract manufacturer
- Principle & Will Biotech (Pinghu) Co., Ltd. Zhejiang, contract manufacturer
- Steris Sterilization Technologies (Suzhou) Ltd Jiangsu, contract manufacturer
- Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Jiangsu, contract manufacturer
- Sterigenics Shanghai ETO Ltd. Shanghai, contract manufacturer
- Zhejiang Baite Medical Appliances Co., Ltd. Zhejiang, contract manufacturer
What Is It?
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code OFR?
Tracheobronchial Suction Catheter Kit is FDA product code OFR, Class 1, 21 CFR 868.6810.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 7 recalls under this product code since 2023. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Nonconforming Material/Component (1) and Labeling Change Control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.